For purposes of this part,diagnostic radiopharmaceutical means:
(a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or
(b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.
authority: 15 U.S.C. 1451-1561;
21 U.S.C. 321,
351,
352,
353,
355,
356b,
360,
360c-360f,
360h-360j,
371,
374,
379e,
381;
42 U.S.C. 216,
241,
262,
263,
264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (
21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127
source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.
cite as: 21 CFR 601.31